Clinical Investigation of Infections Due to Leishmanial Parasites

This study has been completed.

First Received: November 3, 1999 Last Updated: March 3, 2008 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001169

Purpose

Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. Both non-specific and antigen-specific humoral and cellular immune responses will be assessed. Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

Condition
Leishmaniasis Leishmaniasis, Visceral

Study Type:	Observational
Official Title:	Clinical Investigation of Infections Due to Leishmanial Parasites

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	250
Study Start Date:	December 1979
Estimated Study Completion Date:	February 2001

Detailed Description:

The main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the Peace Corps, Smithsonian Institution, tourists, etc.). In the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. We also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. In addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Must be between the ages of 1 and 65 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001169

Locations

United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Publications:

Ponce C, Ponce E, Morrison A, Cruz A, Kreutzer R, McMahon-Pratt D, Neva F. Leishmania donovani chagasi: new clinical variant of cutaneous leishmaniasis in Honduras. Lancet. 1991 Jan 12;337(8733):67-70.

Velasco O, Savarino SJ, Walton BC, Gam AA, Neva FA. Diffuse cutaneous leishmaniasis in Mexico. Am J Trop Med Hyg. 1989 Sep;41(3):280-8.

Badaro R, Falcoff E, Badaro FS, Carvalho EM, Pedral-Sampaio D, Barral A, Carvalho JS, Barral-Netto M, Brandely M, Silva L, et al. Treatment of visceral leishmaniasis with pentavalent antimony and interferon gamma. N Engl J Med. 1990 Jan 4;322(1):16-21.

Study ID Numbers:	790144, 79-I-0144
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001169 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Chemotherapy
Cytokines
Immunology
Kala-Azar
Leishmaniasis

Additional relevant MeSH terms:

Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases
Skin Diseases, Parasitic

Parasitic Diseases
Sarcomastigophora Infections
Mastigophora Infections
Leishmaniasis, Visceral
Infection

ClinicalTrials.gov processed this record on November 05, 2009